RBFF

General

Practical Guide On The List Of Active Substance And Product Suppliers

Di: Amelia

Authentic version: Only the Article 95 list published on this website in PDF format is deemed authentic. The XLS version is made available as a courtesy in order to facilitate This document is intended to provide additional guidance for ASMF holders on completing the Annex 2-Letter of Access, the Annex 3-Submission Letter and Administrative Details for

Information and guidance for suppliers

Active pharmaceutical ingredients manufacturer

MDR-Practical Guide Implementation of Regulation EU 2017/745 (MDR) Requirements for Suppliers of Medical Devices and Materials used to Manufacture Medical Devices All This document provides practical and technical support on the use of the Electronic Application Forms (eAFs) for human and veterinary medicinal products, and in addition to the regulatory If you are a supplier, there are dedicated guidance products to help you prepare and to support you as you begin to do business under the new regime. A short guide for

The list is structured per Active Substances (AS) and product-types (PT). It includes the name and country of the relevant suppliers, if they are substance suppliers and/or product supplier, and Since the approval of active substances relates to specific product-types, an approval application also relates to a specific active substance/product-type combination. To facilitate this process, A substance supplier is an entity who manufactures or imports a relevant substance on its own or in biocidal products. A product supplier is an entity who manufactures or makes available on

The approval of an active substance is granted for a defined number of years, not exceeding ten years. A similar process takes place for the renewal of the approval of an active substance, Companies making available on the market biocidal products had to ensure that either their substance or product suppliers or themselves are included in the Article 95 list under the

To promote fair competition (and prevent “free-riding”), ECHA has compiled the so-called “Article 95 list”. This list includes only suppliers who verifiably

As specified in Article 95(2), as of 1 September 2015, biocidal products consisting of, containing or generating, a relevant substance should not be made available on the market if neither “the In all cases the AP should contain sufficient information to enable the Applicant/MA holder to take full responsibility for an evaluation of the suitability of the specification for the active substance

  • Q 1 A Stability Testing of new Drug Substances and Products
  • Practical User Guide for Electronic Application Forms (eAF
  • Authorisation of biocidal products

This document provides guidance on photostability information to be submitted in the application for marketing authorisation for new active substances and associated medicinal products. The guideline seeks to exemplify the core stability data package for new drug substances and products, but leaves sufficient flexibility to encompass the variety of different practical situations

Quality: active substance

In addition, active substances, which are present in certain medicinal products such as vaccines or cell-therapy medicinal products, do not fit with the concept of a ‘well-defined’ active substance.

An active substance is any substance or mixture of substances intended to be used in the manufacture of a medicinal product and that, when used in its production, becomes an active

Substances restricted under REACH The table below is the Annex XVII to REACH and includes all the restrictions adopted in the framework of REACH and the previous legislation, Directive Article 95 imposes a duty on those offering BPs on the market. Additionally, they must confirm inclusion of “substance supplier” or “product supplier” listed by ECHA under Article 95 for the

First, from 1 September 2015, only biocidal products consisting of, containing, or generating an active substance, sourced from a “substance supplier” or “product supplier” included on the

Concerning monographs on medicinal products, the European or national pharmacopoeiae define the reference quality level. In the marketing authorisation application, the applicant should

The list below contains all the guidance documents which are available, or will be available, medicinal products subject on this website. These documents have been developed with the participation of Member States,

List of substances · IRIS

Conducting studies to establish the risks of using biocidal products is expensive. Applying for a review of an active substance is also expensive. These costs The Candidate drug substances List of substances of very high concern (SVHC) now contains 250 entries for chemicals that can harm people or the environment. Companies are responsible for managing

The European Chemicals Agency (ECHA) is responsible for the publication of the list of relevant substances and the respective substance and product suppliers, in accordance with Article 95

The Candidate List of substances of very high concern (SVHC) now contains 250 entries for and the contents should not chemicals that can harm people or the environment. Companies are responsible for managing

Use the dropdown arrow at the top of any column to search, filter or sort. Details The BPR active substance lists for GB and NI combines separate lists of all the biocidal active substances

As the first step, the active substance is evaluated and, provided the criteria are fulfilled, is product types PT then approved in a specified product-type (PT). The second step is the authorisation of each BP

The guideline seeks to exemplify the core stability data package required for such active substances and finished products, but leaves sufficient flexibility to encompass the variety of

The European Union reference dates (EURD) list is a comprehensive list of active substances and combinations of active substances contained in medicinal products subject to different This document represents voluntary guidance for the excipient industry and the contents should not be interpreted as regulatory requirements. Alternatives to the approaches in this guide may Existing active substance The Review Programme is the name commonly used for the work programme for the examination of existing biocidal active substances contained in biocidal

How to search You can view the information on biocidal active substances in two ways: – per specific active substance and product-type combination (use the Search tab); and – as a The BPR stipulates that the costs associated with active substance approval are to be shared among the suppliers of a given active substance. In

Guidance on active substances and suppliers (Article 95 list) Volume 5 Describes the obligations under Article 95 of the Biocidal Products Regulation and how to fulfil them. Applies to: Northern Approval of active substances – ECHA website Practical guide on the approval of biocidal active substances Biocidal Products Committee BPC opinions on active substance approval